Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer

Study summary

This is a phase II, open-label, single arm, single-stage study. Both, chemo-sensitive and chemo-resistant patients will be enrolled and treated with 4 cycles of combination of Guadecitabine and carboplatin

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGuadecitabine and Carboplatin

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 20, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Shadia Jalal, MD

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Shadia Jalal, MD
Interventions being studied: Drug: Guadecitabine; Drug: Carboplatin

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Male or female subjects, age ≥ 18 years.
Histological or cytological diagnosis of small cell lung cancer. Subjects must have extensive-stage disease is defined as disease beyond the ipsilateral hemithorax, mediastinum and ipsilateral supraclavicular area and including malignant pleural or pericardial effusion or hematogenous metastases.
Patient should not have received more than 1 prior line of chemotherapy (could have received immunotherapy which does not count as chemotherapy).
ECOG PS 0-1
Measurable disease as per RECIST v1.1. Subjects may have bone-only disease. NOTE: Bone-only subjects are eligible if their disease can be documented/evaluated by bone scans, CT or MRI. Their disease will be assessed using MD Anderson criteria. NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation.
Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements:
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1,500/mm3
Platelet count ≥ 100,000/mm3
Total bilirubin ≤ 1.5 x upper limit of normal (ULN). For subjects with Gilbert's Disease, total bilirubin ≤ 3 x ULN
ALT and AST ≤ 2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤ 5×ULN
International Normalized Ratio (INR) ≤1.5, if not therapeutically anticoagulated. Subjects who are being therapeutically anticoagulated may be included provided that the anticoagulation regimen is stable and closely monitored.
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute/1.73 m2 as determined using the Cockcroft-Gault formula.
Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.
Male and female subjects of child- bearing potential must agree to use an effective method of birth control from the screening visit through 6 months after the last dose of study drug.

Reasons someone may not be able to joinExclusion criteria

Platinum refractory disease defined as disease progression during first line platinum containing chemotherapy regimen. Progression following platinum based therapy is allowed.
Prior therapy with a hypomethylating agent.
Previously untreated (non-irradiated), symptomatic brain metastases. No prior treatment is required for non-symptomatic brain metastases. Previously treated symptomatic brain metastases are permitted.
Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. (Suppressive therapy for chronic infections allowed, for example: Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy.)
Hypersensitivity to (IMP) or components of the study treatment regimen.
Treated with any investigational drug within 3 weeks of first dose of study treatment.
Pregnant or breastfeeding.
Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Indiana Univeristy Melvin and Bren Simon Cancer CenterIndianapolis, Indiana
IU Health Ball Memorial Cancer CenterMuncie, Indiana
University of Virginia Health SystemCharlottesville, Virginia
University of Wisconsin, Clinical Cancer CenterMilwaukee, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 20, 2023. Always confirm current availability with the study team.

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